China Joins IMDRF’s Safety Information Exchange Program

Regulatory NewsRegulatory News | 09 October 2019 |  By 

China’s National Medical Products Administration (NMPA) has joined an International Medical Device Regulators Forum (IMDRF) program that allows for the rapid exchange of safety and adverse event data, according to reports from the IMDRF meeting in Russia last month.

NMPA now joins regulators across Europe, Australia, Canada, Japan, Singapore and the US in the IMDRF National Competent Authority Report Exchange, according to a report from state media last month.

The exchange allows regulators to share information that may lead to public health issues. Participants have noted the need for more bilateral confidentiality arrangements to exchange confidential information.

China, which is also on the IMDRF management committee, led further discussions on a proposed update to IMDRF device clinical evaluations, which consultancy China Med Device said also was finalized at the Russia meeting.

In addition, discussions at the September IMDRF meeting focused on the use of artificial intelligence in health care and the associated regulatory challenges.

“Uncertainty about regulatory appreciation of AI in Healthcare is leading to a variety of national legislative initiatives, risking serious fragmentation and limitation of exploiting what AI has to offer,” the workshop agenda noted.


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